Data updated: May 26, 2026
OPDIVO QVANTIG (nivolumab)
Programmed Death Receptor-1-directed Antibody Interactions Genetic Support
Oncology
Approved 2024-12-27
OPDIVO QVANTIG is indicated for the treatment of Renal Cell Carcinoma; Melanoma; Non-Small Cell Lung Cancer.
How OPDIVO QVANTIG Works
Nivolumab is a monoclonal antibody that binds to the PD-1 receptor on T cells, blocking its interaction with PD-L1 and PD-L2 ligands. By disrupting this pathway, the drug prevents the inhibition of T-cell activity and releases the body's anti-tumor immune response. The hyaluronidase component functions by temporarily depolymerizing hyaluronan, a polysaccharide in the subcutaneous tissue's extracellular matrix. This increases the permeability of the tissue at the injection site to facilitate drug delivery, a process that is reversible within 48 hours.
3
Indications
--
Phase 3 Trials
1
Years on Market
Details
- Status
- Prescription
- First Approved
- 2024-12-27
- Revenue
- $133M (Q4-2025)
- Routes
- SUBCUTANEOUS, INJECTION
- Dosage Forms
- INJECTABLE
OPDIVO QVANTIG Approval History
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2024 to 2026 · 2 indication expansions
What OPDIVO QVANTIG Treats
3 indicationsOPDIVO QVANTIG is approved for 3 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Renal Cell Carcinoma
- Melanoma
- Non-Small Cell Lung Cancer
Source: FDA Label
OPDIVO QVANTIG Target & Pathway
ProTarget
An immune checkpoint receptor on T-cells that acts as an 'off switch' for immune responses. Cancer cells often exploit PD-1 by expressing its ligands (PD-L1/PD-L2), allowing tumors to evade immune detection. Blocking PD-1 releases this brake, enabling T-cells to recognize and attack cancer cells.
Pathway Context
PD-1 on T-cells binds to PD-L1/PD-L2 on tumor cells, suppressing immune attack
PD-L1 (Programmed Death-Ligand 1) ligand
A protein expressed on tumor cells and immune cells that binds to PD-1 on T-cells, suppressing immune responses. Many cancers overexpress PD-L1 to avoid immune attack. Blocking PD-L1 prevents this immune suppression, allowing the body's T-cells to fight cancer.
PD-L2 (Programmed Death-Ligand 2) ligand
A second ligand for PD-1, expressed on antigen-presenting cells and some tumors. PD-L2 binds PD-1 with higher affinity than PD-L1 but is less widely expressed. Drugs blocking PD-1 prevent both PD-L1 and PD-L2 interactions.
OPDIVO QVANTIG Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
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Same target(s) AND same indication — head-to-head.
MoA expansion candidates
9
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
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What's emerging in OPDIVO QVANTIG's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OPDIVO QVANTIG treats. First-in-class if their pivotal trials read out positive.
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Uliledlimab TJ004309
TJ Biopharma Co., Ltd. NT5E · monoclonal antibody (anti-CD73) · 1 Phase 3 trial
Drugs Similar to OPDIVO QVANTIG
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
1188 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05896839 | NCI-2023-04306 NCI-2023-04306, ETCTN10614 | Ph 1, Ph 2 | recruiting | Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer |
| NCT03604991 | NCI-2018-01575 NCI-2018-01575, EA2174 | Ph 2, Ph 3 | suspended | Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery |
| NCT04310007 | NCI-2020-01541 NCI-2020-01541, EA5191 | Ph 2 | active not recruiting | Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer |
| NCT04759586 | NCI-2021-01071 NCI-2021-01071, ANHL1931 | Ph 3 | active not recruiting | Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma |
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT05987241 | NCI-2023-05980 NCI-2023-05980, A032103 | Ph 2, Ph 3 | recruiting | Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study |
| NCT05111574 | NCI-2021-11794 NCI-2021-11794, A091903 | Ph 2 | recruiting | Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery |
| NCT03686124 ACTengine | IMA203-101 | Ph 1, Ph 2 | recruiting | ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors |
| NCT06325683 | NCI-2024-01995 NCI-2024-01995, A072201 | Ph 2 | suspended | Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma |
| NCT03033446 | CA209-678 | Ph 2 | completed | Study of Y90-Radioembolization With Nivolumab in Asians With Hepatocellular Carcinoma |
| NCT07293351 | CA266-0008 2025-523637-26, U1111-1327-6332 | Ph 1, Ph 2 | recruiting | A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) |
| NCT07572123 | NCI-2026-03186 NCI-2026-03186, EA4241 | Ph 2, Ph 3 | not yet recruiting | Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem Cell Transplant Alone for High-risk Patients With Relapsed or Refractory Hodgkin Lymphoma |
| NCT02496208 | NCI-2014-02379 NCI-2014-02379, 15-C-0160 | Ph 1 | active not recruiting | Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors |
| NCT01896999 | NCI-2013-01275 NCI-2013-01275, E4412 | Ph 1, Ph 2 | active not recruiting | Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma |
| NCT05136196 | NCI-2021-12653 NCI-2021-12653, S2101 | Ph 2 | recruiting | BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study |
| NCT04317105 | NCI-2020-01917 NCI-2020-01917, NCI10221 | Ph 1, Ph 2 | active not recruiting | Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN |
| NCT05675410 | NCI-2022-10845 NCI-2022-10845, AHOD2131 | Ph 3 | recruiting | A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab |
| NCT04929028 | NCI-2021-06041 NCI-2021-06041, AMC-110 | Ph 2 | active not recruiting | Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer |
| NCT04840589 | NCI-2021-02850 NCI-2021-02850, HCC#21-211 | Ph 1 | suspended | Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors |
| NCT03866382 | NCI-2019-01266 NCI-2019-01266, A031702 | Ph 2 | recruiting | Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors |
| NCT03502733 | NCI-2017-02249 NCI-2017-02249, NCI CC 18-C-0122 | Ph 1 | active not recruiting | Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma |
| NCT03816358 | NCI-2019-00242 NCI-2019-00242, PJC-026 | Ph 1 | active not recruiting | Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer |
| NCT03793166 | NCI-2018-03694 NCI-2018-03694, A031704 | Ph 3 | active not recruiting | Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study |
| NCT02595944 ANVIL | NCI-2015-01916 NCI-2015-01916, s16-02074 | Ph 3 | active not recruiting | Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer (An ALCHEMIST Treatment Trial) |
| NCT05904080 | NCI-2023-04469 NCI-2023-04469, A092105 | Ph 2 | recruiting | Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer |
| NCT04929041 | NCI-2021-06042 NCI-2021-06042, A082002 | Ph 2, Ph 3 | suspended | Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative |
| NCT03233711 | NCI-2017-01347 NCI-2017-01347, EA2165 | Ph 3 | active not recruiting | Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer |
| NCT05272384 | NCI-2022-01799 NCI-2022-01799, S22-00427 | Ph 1 | recruiting | Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma |
| NCT02978625 | NCI-2016-01804 NCI-2016-01804, CINJ #091701 | Ph 2 | active not recruiting | Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers |
| NCT04652960 | NCI-2020-11641 NCI-2020-11641, 10347 | Ph 1 | active not recruiting | Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome |
| NCT03604978 | NCI-2018-01560 NCI-2018-01560, 201901009 | Ph 1, Ph 2 | active not recruiting | Nivolumab and Multi-fraction Stereotactic Radiosurgery With or Without Ipilimumab in Treating Patients With Recurrent Grade II-III Meningioma |
| NCT03811015 | NCI-2019-00179 NCI-2019-00179, EA3161 | Ph 3 | active not recruiting | Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer |
| NCT03816345 | NCI-2019-00241 NCI-2019-00241, 10204 | Ph 1 | recruiting | Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO |
| NCT02339571 | NCI-2014-02674 NCI-2014-02674, EA6141 | Ph 2, Ph 3 | active not recruiting | A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma |
| NCT06203600 | NCI-2023-11064 NCI-2023-11064, S2303 | Ph 2, Ph 3 | recruiting | Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial |
| NCT06029270 | NCI-2023-06678 NCI-2023-06678, NRG-HN011 | Ph 2 | recruiting | Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer |
| NCT02834013 | NCI-2016-01041 NCI-2016-01041, S1609 | Ph 2 | active not recruiting | Nivolumab and Ipilimumab in Treating Patients With Rare Tumors |
| NCT06064097 | NCI-2023-07208 NCI-2023-07208, ARAR2221 | Ph 2 | recruiting | A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC) |
| NCT01703949 results posted | 7808 NCI-2012-01696, 7808 | Ph 2 | active not recruiting | Brentuximab Vedotin With or Without Nivolumab in Treating Patients With Relapsed or Refractory CD30+ Lymphoma |
| NCT07405164 | 6482-043 U1111-1325-4582, 2025-524160-38-00 | Ph 3 | recruiting | Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) |
| NCT05919264 | FOG-001-101 | Ph 1, Ph 2 | recruiting | FOG-001 in Locally Advanced or Metastatic Solid Tumors |
| NCT04205409 results posted | RG1005491 NCI-2019-08192, 10388 | Ph 2 | completed | Nivolumab for Relapsed, Refractory, or Detectable Disease Post Chimeric Antigen Receptor T-cell Treatment in Patients With Hematologic Malignancies |
| NCT02314169 results posted | NCI-2014-02420 NCI-2014-02420, NCI9673 | Ph 2 | active not recruiting | Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer |
| NCT03038672 results posted | NCI-2017-00120 NCI-2017-00120, MC168D | Ph 2 | active not recruiting | Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas |
| NCT06534983 IMCODE004 | BO45230 2023-509023-40-00 | Ph 2 | recruiting | A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-risk Muscle-invasive Urothelial Carcinoma (MIUC) |
| NCT04464759 LIMIT | UPCC 01620 IRB#835033 | Ph 1, Ph 2 | recruiting | A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma |
| NCT03767582 results posted | J18163 IRB00190660 | Ph 1, Ph 2 | completed | Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. |
| NCT07128680 | 25160 NCI-2025-05679, 25160 | Ph 1 | recruiting | Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer |
| NCT07576725 | RG1125119 NCI-2026-01874 | Ph 2 | not yet recruiting | Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial |
| NCT06632327 | CTIU2317-A082304-S2402 NCI-2024-06356 | Ph 3 | recruiting | Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer |
Showing 50 of 1188 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OPDIVO QVANTIG FDA Label Details
Indications & Usage
FDA Label (PDF)OPDIVO QVANTIG is indicated for the treatment of Renal Cell Carcinoma; Melanoma; Non-Small Cell Lung Cancer.
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- • Q4-2025: $133M
- • Historical trend analysis
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- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.